APC™ Flash-Free Clarity™ Advanced
Clarity(TM) ADVANCED Ceramic Bracket APC(TM) Flash-Free MBT(TM) L1,2 -6T/0A .022 5/Pk
1manufacturer
121catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | 3M Unitek, United States |
|---|---|
| FDA product code | NJM |
| Device type | Bracket, Ceramic, Orthodontic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5470 |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4006-307 | 5 | In distribution | |
| 4006-256 | 5 | In distribution | |
| 4006-218 | 5 | In distribution | |
| 4006-275 | 5 | In distribution | |
| 4006-258 | 5 | In distribution | |
| 4006-356 | 5 | In distribution | |
| 4006-108 | In distribution | ||
| 4006-229 | 5 | In distribution | |
| 4006-257 | 5 | In distribution | |
| 4006-100 | In distribution | ||
| 4006-355 | 5 | In distribution | |
| 4006-211 | 5 | In distribution | |
| 4006-135 | In distribution | ||
| 4006-123 | In distribution | ||
| 4006-261 | 5 | In distribution | |
| 4006-109 | In distribution | ||
| 4006-121 | In distribution | ||
| 4006-264 | 5 | In distribution | |
| 4006-251 | 5 | In distribution | |
| 4006-318 | 5 | In distribution | |
| 4006-209 | 5 | In distribution | |
| 4006-371 | 5 | In distribution | |
| 4006-322 | 5 | In distribution | |
| 4006-321 | 5 | In distribution | |
| 4006-133 | In distribution | ||
| 4006-372 | 5 | In distribution | |
| 4006-138 | In distribution | ||
| 4006-253 | 5 | In distribution | |
| 4006-279 | 5 | In distribution | |
| 4006-353 | 5 | In distribution | |
| 4006-276 | 5 | In distribution | |
| 4006-315 | 5 | In distribution | |
| 4006-306 | 5 | In distribution | |
| 4006-205 | 5 | In distribution | |
| 4006-103 | In distribution | ||
| 4006-101 | In distribution | ||
| 4006-206 | 5 | In distribution | |
| 4006-368 | 5 | In distribution | |
| 4006-212 | 5 | In distribution | |
| 4006-208 | 5 | In distribution | |
| 4006-330 | 5 | In distribution | |
| 4006-260 | 5 | In distribution | |
| 4006-131 | In distribution | ||
| 4006-302 | 5 | In distribution | |
| 4006-375 | 5 | In distribution | |
| 4006-222 | 5 | In distribution | |
| 4006-104 | In distribution | ||
| 4006-354 | 5 | In distribution | |
| 4006-116 | In distribution | ||
| 4006-351 | 5 | In distribution | |
| 4006-126 | In distribution | ||
| 4006-225 | 5 | In distribution | |
| 4006-217 | 5 | In distribution | |
| 4006-360 | 5 | In distribution | |
| 4006-267 | 5 | In distribution | |
| 4006-224 | 5 | In distribution | |
| 4006-223 | 5 | In distribution | |
| 4006-252 | 5 | In distribution | |
| 4006-326 | 5 | In distribution | |
| 4006-316 | 5 | In distribution | |
| 4006-280 | 5 | In distribution | |
| 4006-128 | In distribution | ||
| 4006-112 | In distribution | ||
| 4006-271 | 5 | In distribution | |
| 4006-105 | In distribution | ||
| 4006-125 | In distribution | ||
| 4006-213 | 5 | In distribution | |
| 4006-102 | In distribution | ||
| 4006-226 | 5 | In distribution | |
| 4006-118 | In distribution | ||
| 4006-350 | 5 | In distribution | |
| 4006-305 | 5 | In distribution | |
| 4006-230 | 5 | In distribution | |
| 4006-221 | 5 | In distribution | |
| 4006-325 | 5 | In distribution | |
| 4006-357 | 5 | In distribution | |
| 4006-114 | In distribution | ||
| 4006-216 | 5 | In distribution | |
| 4006-361 | 5 | In distribution | |
| 4006-207 | 5 | In distribution | |
| 4006-317 | 5 | In distribution | |
| 4006-362 | 5 | In distribution | |
| 4006-364 | 5 | In distribution | |
| 4006-115 | In distribution | ||
| 4006-250 | 5 | In distribution | |
| 4006-202 | 5 | In distribution | |
| 4006-311 | 5 | In distribution | |
| 4006-313 | 5 | In distribution | |
| 4006-310 | 5 | In distribution | |
| 4006-268 | 5 | In distribution | |
| 4006-117 | In distribution | ||
| 4006-308 | 5 | In distribution | |
| 4006-367 | 5 | In distribution | |
| 4006-136 | In distribution | ||
| 4006-272 | 5 | In distribution | |
| 4006-359 | 5 | In distribution | |
| 4006-111 | In distribution | ||
| 4006-324 | 5 | In distribution | |
| 4006-323 | 5 | In distribution | |
| 4006-301 | 5 | In distribution | |
| 4006-312 | 5 | In distribution | |
| 4006-215 | 5 | In distribution | |
| 4006-106 | In distribution | ||
| 4006-110 | In distribution | ||
| 4006-201 | 5 | In distribution | |
| 4006-107 | In distribution | ||
| 4006-380 | 5 | In distribution | |
| 4006-172 | In distribution | ||
| 4006-262 | 5 | In distribution | |
| 4006-210 | 5 | In distribution | |
| 4006-376 | 5 | In distribution | |
| 4006-259 | 5 | In distribution | |
| 4006-255 | 5 | In distribution | |
| 4006-254 | 5 | In distribution | |
| 4006-379 | 5 | In distribution | |
| 4006-113 | In distribution | ||
| 4006-329 | 5 | In distribution | |
| 4006-309 | 5 | In distribution | |
| 4006-119 | In distribution | ||
| 4006-352 | 5 | In distribution | |
| 4006-358 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuicKlear® | Forestadent Bernhard Förster GmbH | 841 |
| Bracket, Ceramic, Orthodontic | Flexmedics | 600 |
| Experience | GC Orthodontics America Inc. | 500 |
| TruKlear | Forestadent Bernhard Förster GmbH | 401 |
| Chic | GC Orthodontics America Inc. | 348 |
| Bracket, Ceramic, Orthodontic | Forestadent Bernhard Förster GmbH | 342 |
| IN-Ovation® C | Dentsply Sirona Orthodontics Inc. | 327 |
| Intrigue | Lancer Orthodontics, Inc. | 253 |
| Empower Clear | American Orthodontics | 250 |
| Empower Clear Bracket | American Orthodontics | 250 |
| InVu Ceramic Brackets | TP Orthodontics, Inc. | 226 |
| RadiancePlus | American Orthodontics | 179 |
Showing 12 of 399. All products under Bracket, Ceramic, Orthodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102803 | 2011-02-17 |
| K062305 | 2006-10-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.